A Pilot Trial of the Non-invasive H.G.R Glucometer

NCT ID: NCT04658082

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-07

Study Completion Date

2020-12-01

Brief Summary

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A pilot study evaluating the accuracy of a non-invasive glucose monitor (GWave) with venous glucose measured by core laboratory during a glucose tolerance test (GTT) in patients with type 2 diabetes.

The study is conducted on 5 subjects undergoing a 75gr GTT, with blood glucose measured at baseline and at 8 time points up to 180 minutes post glucose ingestion both by GWave non-invasive glucometer and by core lab glucose measurement.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Non invasive glucose monitor

Single arm. All subjects will have glucose levels measured both by non invasive glucometer and by core lab

Group Type OTHER

H.G.R (GWave) non-invasive glucometer

Intervention Type DEVICE

Glucose tolerance test

Interventions

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H.G.R (GWave) non-invasive glucometer

Glucose tolerance test

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Male or female.
3. Age above or equal to 18 years at the time of signing informed consent.
4. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
5. HbA1c of 6.0-8.0% .

Exclusion Criteria

1. Participants under the age of 18 years
2. pregnant women or patients with normal blood glucose.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Amir Tirosh

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Amir Tirosh

Director, Division of Endocrinology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Amir Tirosh, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Sheba-19-6335-at-ctil

Identifier Type: -

Identifier Source: org_study_id

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